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Orexigen Therapeutics, Inc. (OREX - Snapshot Report) recently provided an update on its obesity candidate, Contrave. The company, which had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) in Jan 2011 for Contrave, said that it could be in a position to resubmit the NDA for Contrave in the second half of 2013.
At the time of issuing the CRL, the FDA had expressed concerns regarding the long-term cardiovascular safety profile of Contrave and had asked Orexigen to conduct an additional study. The FDA requested a randomized, double-blind, placebo-controlled trial of sufficient size and duration which would show that the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave does not adversely affect its benefit-risk profile.
In Feb 2012, the company reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the Contrave outcomes trial and the Light Study was initiated in Jun 2012.
The company said that the Division of Metabolism and Endocrinology Products (DMEP) has proposed a resubmission procedure under which an interim analysis report submitted by the independent Data Monitoring Committee of the Light Study can be used for the resubmission of the Contrave NDA.
While the timing of the interim analysis depends on the rate of occurrence of major adverse cardiovascular events in the Light Study, Orexigen is hopeful of gaining approval in early 2014.
The company has a collaboration agreement with Takeda for the development and commercialization of Contrave in the US, Canada and Mexico. Takeda has experience in the metabolic disorder market which should prove beneficial. However, we note that Contrave, once launched, will be a late entrant in the obesity market. Last year, two obesity prevention drugs were approved: Arena Pharmaceuticals, Inc.’s (ARNA - Snapshot Report) Belviq and VIVUS Inc.’s (VVUS - Snapshot Report) Qsymia.
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